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Registration Dossier
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EC number: 219-417-6 | CAS number: 2432-99-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2c: comparable to guideline study with acceptable restrictions. No GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: JO RF of 1971-04-21 and completed with JO RF of 1973-06-05
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 11-aminoundecanoic acid
- EC Number:
- 219-417-6
- EC Name:
- 11-aminoundecanoic acid
- Cas Number:
- 2432-99-7
- Molecular formula:
- C11H23NO2
- IUPAC Name:
- 11-aminoundecanoic acid
- Reference substance name:
- RILSAN
- IUPAC Name:
- RILSAN
- Reference substance name:
- acide omega amino undecanoïque
- IUPAC Name:
- acide omega amino undecanoïque
- Details on test material:
- no data
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet: 200g per animal per day, classic granules (from Sanders)
- Water ad libitum
- Other: rabbits were vaccinated before the test against pasteurellosis and myxomatosis
Only animals with normal eye conditions were selected for the test, any with ocular lesion were rejected.
ENVIRONMENTAL CONDITIONS
- Temperature: 22+- 2°C
- Humidity: 55% +- 10%
- Air changes: 12 times per hr
- Photoperiod (12hrs dark / 12hrs light)
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye
- Amount / concentration applied:
- - Amount applied: 100 mg per rabbit
- substance instilled in the right eye (left eye = control) - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- no washing was done
observations of the conditions of the cornea were done with the naked eye with an ophtalmoscop of Heine (Microflex C-00. 13. 101)
SCORING SYSTEM:
the scoring is based on the same parameter and symptoms as in the OECD guideline : cornea, conjunctive, iris and chemosis.
Other parameters were observed in this study like discharge, ulceration and granulation of the cornea.
Then the calculation for the interpretation of the results is slightly different in that the scores are added and a coefficient is applied : 2 for conjunctive and chemosis parameter and 5 for iris anc cornea scores.
As the evaluation is based on the same parameters and symptoms and the interpretations of the results are coherent, OECD calculations are used here.
TOOL USED TO ASSESS SCORE: hand-slit lamp or ophtalmoscop of Heine.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.27
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- for raw data and scoring according to OECD guideline see table 1 in the "remarks on results" freetext
- Other effects:
- Only a slight discharge was observed 1h after instillation in the six rabbits. After 1 day no more discharge was observed in all the rabbits.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
| Score at time point/ Reversibility | Cornea Max. score: 4 |
Iris Max. score: 2 |
Conjunctivae Max. score: 3 |
Chemosis Max. score: 4 |
| 60 min | 0/0/0/0/0/0 | 1/1/1/1/1/1 | 1/1/1/1/1/1 | 2/1/1/2/2/2 |
| 24 h | 0/0/0/0/0/0 | 0/0/0/0/1/0 | 0/1/0/0/1/1 | 1/0/0/0/1/1 |
| 48 h | 0/0/0/0/0/0 | 1/0/0/0/0/0 | 1/0/0/1/0/0 | 0/0/0/0/0/0 |
| 72 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
| Average 24h, 48h, 72h | 0 | 0.11 | 0.27 | 0.16 |
| Reversibility*) | - | c. | c. | c. |
| *) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible | ||||
After 72h the animals were kept under observation but animals kept with normal eyes. The reversibility was complete.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- Under the conditions of this test, acide omega amino undecanoique was not irritating considering EU and GHS classifications
- Executive summary:
In an ocular irritation test (IFREB, 1978), six male albino New Zealand white rabbits were used. The test substance (acide omega amino undecanoique) was introduced into the animal's right eye, the animal's left eye served as a control. Animals were observed for 7 days. Irritation was scored following a grading of ocular lesions similar to that of the guideline OECD 405. The results showed that the substance was slightly irritating. After one hour the 6 rabbits showed chaemosis, discharge, enanthema and congestion reactions. Most of these effects decreased after 24 hr and desappeared totally after 3 days.The scores (mean: 24, 48 and 72 hr scores) obtained for chemosis, redness of conjunctivae, iris lesion and cornea opacity were respectively 0.26, 0.27, 0.11 and 0. Under the conditions of this test, the substance is considered as not irritating according to EU and GHS classification.
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